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EC number: 266-104-5 | CAS number: 66069-34-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.
- Adequacy of study:
- key study
- Study period:
- testing was performed on the 11th March 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- In order to comply with regulatory requirements, work was carried out in an attempt to generate atmospheres of the test item. Had this work been successful, the study would have proceeded such that it would have complied with the method described in the OECD Guidelines for Testing of Chemicals (2009) No. 436 “Acute Inhalation Toxicity – Acute Toxic Class Method”.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- TBA Clavulanate
- IUPAC Name:
- TBA Clavulanate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification : tBA Clavulanate
Batch number : 13c30367
Description : Off-white powder
Assay (O.A.B.S.F.) : 100.88 %w/w
Date received : 01 March 2013
Expiry Date : 11 February 2016
Storage conditions : Cold at approximately 4°C, in the dark over silica gel
Constituent 1
Test animals
- Species:
- other: not applicable as no actual testing was conducted
- Strain:
- other: not applicable as no actual testing was conducted
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not applicable as no actual testing on animals was conducted
Administration / exposure
- Route of administration:
- other: not applicable as no actual testing on animals was conducted
- Type of inhalation exposure:
- other: not applicable as no actual testing on animals was conducted
- Vehicle:
- other: not applicable as no actual testing on animals was conducted
- Details on inhalation exposure:
- not applicable as no actual testing on animals was conducted
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 0 d
- Concentrations:
- not applicable as no actual testing on animals was conducted
- No. of animals per sex per dose:
- not applicable as no actual testing on animals was conducted
- Control animals:
- other: not applicable as no actual testing on animals was conducted
- Details on study design:
- not applicable as no actual testing on animals was conducted
Results and discussion
Effect levels
- Remarks on result:
- other: It proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals, therefore no actual testing was conducted.
- Mortality:
- Not applicable as no actual testing was conducted
- Clinical signs:
- other: Not applicable as no actual testing was conducted
- Body weight:
- Not applicable as no actual testing was conducted
- Gross pathology:
- Not applicable as no actual testing was conducted
Any other information on results incl. tables
Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.
The dust generation properties of tBA Clavulanate with a particle size of less than 4 μm were shown to be low. It was, therefore, considered not to be possible to generate an atmosphere with a satisfactory particle size from the test item, for use in an inhalation study.
In view of the physical nature of the test item, its apparent low volatility and its’ tendancy to clump, it is considered unlikely to represent a significant hazard by the inhalation route. - Executive summary:
Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.
The dust generation properties of tBA Clavulanate with a particle size of less than 4 μm were shown to be low. It was, therefore, considered not to be possible to generate an atmosphere with a satisfactory particle size from the test item, for use in an inhalation study. In view of the physical nature of the test item, its apparent low volatility and its’ tendancy to clump, it is considered unlikely to represent a significant hazard by the inhalation route.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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